RUO Assay Development

Our assay development services are not limited to predictive markers for clinical use – we also offer services in the development of research or retrospective use (RUO) assays on a range of platforms.

When a biomarker assay is required for trial enrichment, or a patient treatment decision will be made based on the result, assays must be run under CLIA/ GLP. Not all biomarker assays that take place in the clinical trial setting will result in patient treatment decisions; those that are pharmacodynamic markers or assays for research purposes do not require the same level of validation and are typically run retrospectively in batches as the trial progresses.

Although the validation requirements are less stringent, we develop and process these assays under the same quality system and with the same processes and protocols. We also offer the same level of expertise in the development and delivery of multiplex assays for DNA and RNA.

Our Solutions

Determining the optimal platform for the delivery of the assay

Platform migration

Tissue migration studies

Developing reference genes from our proprietary panel

We have extensive experience developing assays from formalin fixed paraffin embedded (FFPE) materials. We offer assays on multiple platforms including qPCR, microarray, next generation sequencing and IHC. More details on the platforms we offer and our quality and accreditation systems can be found in our infrastructure section.

 

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